Category: Clinical research

List of clinical trial registries in the world

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January 26, 2023

7:00 am

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Clinical research

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List of clinical trial registries:

Clinical trial registries list provided here with the website urls.

Clinical trial registry is an official website that allows us to registering the clinical trials. Any body can register the clinical trails in the registry who will sponsor the study or by any organisation who is conducting the study. Usually Pharmaceutical or medical or biotech companies or research institutes will register the trials in the clinical trial registries.

Two types of registries available. They are primary registry and partner registry.

Primary registry:

Primary registries are developed according to the specific criteria given by World Health Organisation (WHO) International Clinical trial registry platform (ICTRP) This specific criteria include these 6 categories. That is Content, quality &validity, Accessibility, Unambiguous Identification, Technical capacity, Administration &governance.  Primary registry meets the requirements of International committee of medical journal editors (ICMJE). Registration of trial in the clinical trial primary registry in the WHO network or USA Clinical trial registry (Clinicaltrials.gov) is mandatory for publishing the study in international biomedical journals. ICMJE announced this statement 15 years back and applicable from July 1st 2005 onwards. All these primary registries are linked to the WHO- ICTRP. ICTRP can directly receive the data from these primary registries.

clinical trial registries

Related: Clinical trials overview

A total number of 16 registries recognized as primary registries in the WHO registry network. Along with these 16 registries Clinical trials.gov (USA) recognized by ICMJE. Along with USA registry Clinicaltrials.gov, these 16 primary registries act as data providers to WHO. This data available in the WHO ICTRP search portal. WHO ICTRP search portal is technically not considered as a clinical trial registry. 

For eg: If you register a clinical trial in any of these 17 clinical trial registries, you can find that trial in WHO ICTRP search portal. Registries registered trail data upload to ICTRP search portal periodically.

Australia, China, UN, EU, Netherlands, USA registries uploaded Friday of the every week. Remaining registries data uploaded monthly basis.Types of clinical trial registries

List of clinical trial registries recognized by WHO network and ICMJE are follows.

List of clinical trial registries (Primary)

1. Australian New Zealand CTR (ANZ Clinical Trial Registry) –  http://www.anzctr.org.au

2. Brazilian CTR (ReBec) – http://www.ensaiosclinicos.gov.br/

3. Chinese CTR (ChiCTR) – http://www.chictr.org.cn/ 

4. Republic of korea Clinical Research Information Service (CRiS), – https://www.who.int/ictrp/network/cris2/en/

5. CTR – India (CTRI) – http://ctri.nic.in

6. Cuban Public Registry of Clinical Trials (RPCEC) – http://registroclinico.sld.cu/

7. European Union CTR (EU-CTR) – https://www.clinicaltrialsregister.eu/

8. German CTR (DRKS)  – https://www.drks.de

9. Iranian Registry of Clinical Trials (IRCT) – https://www.irct.ir/

10. United Kingdom for International Standard Registered Clinical/soCial sTudy Number (ISRCTN) – http://www.isrctn.com/

11. Japan Primary Registries Network (JPRN) – http://rctportal.niph.go.jp/  (It has four networks JapicCTI, JMACCT CTR, jRCT, UMIN CTR )

12. Thai CTR (TCTR) – http://www.clinicaltrials.in.th/

13. The Netherlands National Trial Register (NTR) – https://www.trialregister.nl/

14. Pan African CTR (PACTR) – https://pactr.samrc.ac.za/

15. Peruvian CTR (REPEC) – https://ensayosclinicos-repec.ins.gob.pe

16. Sri Lanka CTR (SLCTR) – http://www.slctr.lk/

 USA – https://clinicaltrials.gov/ (Recognised by ICMJE, It is not in the list of WHO registry network but act as data provider to WHO ICTRP)

WHO ICTRP- http://apps.who.int/trialsearch/ (Technically not called as a clinical trial register)

Related: Job opportunities after pharmacology graduation

Partner registry:  

Partner registries does not meet the requirements of ICMJE. But partner registry meets the WHO ICTRP specific criteria as mentioned above. They are affiliated to ICMJE registered primary registry or Primary registry in WHO network. It is the responsibility of primary registry to make sure that the partner registry meets the WHO registry criteria. ICTRP directly will not have access to receive the data from these partner registries. Along with 16 primary registries two partner registers available. These two registries are affiliated to Chinese clinical trial registry (ChiCTR). Partner registries can also be called as secondary registries. They are as follows.

  1. Centre for Clinical Trials, CTR – Chinese University of Hong Kong – http://www2.ccrb.cuhk.edu.hk/web/
  2. The Acupuncture-Moxibustion Clinical Trial Registry (AMCTR) Beijing
  3. Apart from these registries, other available registries are as follows.
List of clinical trail registries (Regional)
  1. Canadian cancer trials – http://www.canadiancancertrials.ca/ ( Canadian based cancer registry –Only for cancer clinical trails in Canada)
  2. Health Canada Clinical Trial Database – http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdonclin/index-eng.php (It is technically not called as a registry)
  3. Hong Kong University clinical trials registry (HKUCTR)- http://www.hkuctr.com/
  4. Indonesia clinical trial registry- https://ina-registry.org/
  5. NBScience Clinical trial registry  (NBSCTR)- Ukraine – http://www.nbscience.com/
  6. Philippine Health Research Registry (PHRR) – http://registry.healthresearch.ph
  7. Swiss National Clinical Trials Portal (SNCTP) – http://www.kofam.ch/en/swiss -clinical-trials-portal.html
  8. South African National Clinical Trial Register (SANCTR) – http://www.sanctr.gov.za/
  9. Spanish registry of Clinical trials (REec) – https://reec.aemps.es
  10. Tanzania Clinical Trial Registry (TzCTR) – http://www.tzctr.or.tz/  

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List of documents required for Ethics committee (EC) submission

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February 28, 2023

6:00 am

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Clinical research, M Pharmacy freshers

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There are two types of ethics committees(EC) available in India. These are Institutional ethics committee and Independent ethics committee. You can also see the more details about these two ECs here.  Here we have provided a list of documents required for Institutional ethics committee(IEC) for protocol review. Documents requirement also differ from each institutional ethics committees. It is defined according to their standard operating procedures(SOPs). These mentioned documents should be produced in ‘n’ number of sets. Along with these documents hard copies, soft copies should be copied to a CD (Compact  Disk) for reference.   

Overall required documents are as follows

List of Ethics committee documents

  1. Protocol
  2. Case record form
  3. Informed consent form or site specific informed consent form (English copy along with copies in Vernacular languages)
  4. Patient information sheet ( English copy along with copies in vernacular languages)
  5. Patient diary (English copy along with copies in vernacular languages)
  6. Investigator’s brochure
  7. Proposed methods for patient recruitment (Advertisements, Posters etc.)
  8. Clinical Trial Agreement
  9. Protocol signature page
  10. Investigator’s undertaking
  11. Principle Investigator’s Curriculum vitae
  12. Principle investigator’s medical registration certificate
  13. Principle Investigators No conflict of interest statement
  14. Study Insurance
  15. Letter of Indemnification

After completion of submission process along with processing fee cheque, EC will review the documents.

Note: A few ethics committees will have Scientific research society / scientific review board / scientific committees. They will screen and study the submitted documents then forward the project to Ethics committee.

Related: Types of clinical trials

EC will take final decision. Final decision will be decided by voting of ethics committee members. The decision may be anything. Usually types of responses will be given by an Ethics committee are

  1. Approved
  2. Queries raised
  3. Conditionally approved
  4. Rejected

Approved: It is a positive decision for sponsor or study personal. Letter will be issued with protocol number, version number and date. It includes all the details about attended members and list of documents reviewed. It also contains general rules. Those are like inform the progress of study/ Serious adverse events should be informed/ follow the ICMR/ ICH GCP/ Schedule Y guidelines/ study should be registered with CTRI etc. 

Queries raised: In this scenario, EC may raise the queries regarding the study from any point of view (patient safety/ study protocol etc.).

For eg.

1. Explain why ‘n’ numbers of blood tests will be done in short period of time.

2. Explain the rationality for studying the combination of these x and y drugs. Etc.

Receiving queries from the Ethics committee, sponsor need to respond with proper explanation. Required supported documents should be produced in front of EC in the next scheduled meeting with amendment fee.   

Conditional approval: In this case, Ethics committee is okay with the study procedure. EC may instruct that after fulfilling the particular requirement only, this approval is valid.

Rejected: If EC not at all satisfied with the study protocol including unethical procedures. EC may reject the study. Rejection letter will be issued with reasons..